Kornimate/medical-research-clean huggingface dataset:
the effect of discontinuation of renin angiotensin system inhibitors on the perioperative myocardial injury in adult patients undergoing colorectal cancer surgery

Conditions: Myocardium; Injury; Perioperative/Postoperative Complications; Angiotensin-Converting-Enzyme Inhibitor

Summary: the aim of this study is to estimate the effect of discontinuation of ras inhibitors on myocardial injury in cancer patients undergoing major abdominal surgeries.

this is a prospective, open-label, randomized controlled non inferiority trial. participants will be assigned randomly in a 1:1 manner whether to stop or continue ras inhibitors. randomization will be performed using an online program (www.randomizer.com). trial participants and staff will not be blinded to treatment group allocation however, all investigators will be blinded to the primary outcome measure (myocardial injury). after randomization during the preoperative visit, participants will be instructed to stop or continue their ace-i and/or arb according to their allocated group. ace-i and/or arb will be continued or discontinued as per treatment group allocation and this will continue until 24 hours after the end of surgery. since ace-i and arb have different durations of action, participants will receive drug-specific instructions as to when to stop. when the ace-i and/or arb duration of action is ≥24 hours, the drug will be stopped 48 hours prior to surgery. all other ace-i and/or arb will be stopped 24 hours before surgery. renin-angiotensin system inhibitors will be restarted after surgery on the morning of post-operative day one if systolic blood pressure was \>120 mmhg in the previous 12 hours. the anesthetic induction, intraoperative and postoperative management will be managed according to the local policy of the nci by expert anesthesiologists who will be blinded to the patients' groups. troponin-i will be measured at 9 a.m. on the day before surgery and at 9 a.m. on postoperative day one and day two. myocardial injury will be defined as: (troponin-i an increase by 0.015 is considered positive, if the baseline is \<0.05 a. if the baseline is higher than 0.05, an increase by 0.005 is considered positive).

Eligibility criteria:
inclusion criteria: * age \> 18 years * both sexes * asa 2-3 * chronic hypertensive patients (\> 3 months before surgery) controlled on aceis or arbs or combination therapy containing one of the ras inhibitors. * scheduled for major abdominal cancer surgery (surgery with an expected duration of \> 2 h from the surgical incision and a postoperative hospital stay of least three days). exclusion criteria: * patient refusal. * recent myocardial infarction (within 3 months). * any condition, which in the opinion of the treating clinician, would result in the patient being harmed by the cessation of the ace-i and/or arb therapy. * emergency surgery
correlation hand grip strength and walking distance in elderly

Conditions: Coronary Revascularization

Summary: elderly patient post coronary revascularization assessed hand grip strength and changes in six minute walking distance

coronary artery disease causes muscle dysfunction which leads to decreased muscle fitness due to reduced cardiac output, resulting in reduced oxygen uptake from the blood, and further decreases functional capacity or maximum oxygen uptake. the elderly population is an age group at risk of developing coronary artery disease. handgrip strength s a good predictor for assessing overall muscle fitness, where handgrip strength assessment with a dynamometer is one method of determining muscle fitness, one of the factors affecting cardiorespiratory fitness, which can be assessed by the 6-minute walk test. this study wants to determine the correlation between handgrip strength and changes in 6-minute walk test after undergoing phase 2 cardiac rehabilitation in the elderly after coronary revascularization and this study also wants to know the predictive value using the parameters studied.

Eligibility criteria:
inclusion criteria: * post coronary revascularization * mmse \>= 26 bmi 18.5-25 exclusion criteria: * comorbid cardiovascular, lung, kidney and metabolic disease * frailty syndrome
study of immune globulin intravenous (human) gc5107 in pediatric subjects with primary humoral immunodeficiency

Conditions: Primary Immune Deficiency

Summary: the purpose of this study is to evaluate the pharmacokinetics and safety of immune globulin intravenous (human) gc5107 in pediatric subjects with primary humoral immunodeficiency (phid).

this is a prospective, open-label, single-arm, historically controlled, multi-center phase iii study to assess the pharmacokinetics and safety of immune globulin intravenous (human) gc5107 in pediatric subjects aged ≥ 2 years and \< 17 years with phid. subjects will receive intravenous infusions of the investigational product at the same dose and interval as used for their previous immunoglobulin intravenous (igiv) maintenance therapy. gc5107 will be infused every 21 or 28 days for a period of 12 months.

Eligibility criteria:
inclusion criteria: * subject must be ≥ 2 to \< 17 years of age, at the time of signing the informed consent * pediatric subject has a confirmed and documented clinical diagnosis of primary humoral immunodeficiency, including hypogammaglobulinemia or agammaglobulinemia * subject who has received 300 - 900 mg/kg of igiv therapy at 21 or 28 day intervals for at least 3 months prior to this study * subject who has at least 2 documented plasma igg trough level of ≥ 500 mg/dl at two infusion cycles (21 or 28 days) within 12 months prior to enrollment * subject who is willing to comply with all requirements of the protocol exclusion criteria: * subject who has a history of clinically significant reactions or hypersensitivity to igiv or other injectable forms of igg * subject who has iga deficiency and is known to have antibodies to iga * subject who has secondary immunodeficiency * subject who has participated in another clinical study (other than an igiv study) within 3 weeks prior to screening * subject who has been diagnosed with dysgammaglobulinemia or isolated igg subclass deficiency or isolated iga deficiency, or who has clinically significant impairment of cellular or innate immunity at the discretion of the investigator * subject who has received blood products other than human albumin or human immune globulin within 6 months prior to enrollment
the incidence of pelvic hematoma following hysterectomy

Conditions: Hematoma

Summary: hysterectomy is one of the common operations in gynecology. with population aging in modern society, the incidence of these surgeries is expected to increase even more. one of the major complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain, fever, and foul smelling discharge. the incidence of pelvic hematoma is 40%, and varies according to the type of hysterectomy and the diagnostic procedure. those hematoma increase the risk for infection. diagnosis usually is not a clinical one unless symptoms occur, and then the diagnosis is made by ct or ultrasound. number of interventions are mentioned in the literature to try and decrease post operative complications and infections, none have suggested effective enough. this is a prospective study which objective is to characterize the incidence of pelvic hematoma following hysterectomy using ultrasound. the investigators will also try to identify preoperative, intraoperative and postoperative risk factors for infection of this hematomas. this identification might decrease the incidence of postoperative hematoma and infection.

aging in modern society, the incidence of these surgeries is expected to increase even more. one of the major complications of pelvic surgery is symptomatic pelvic hematoma, which can present with pain, fever, and foul smelling discharge. the incidence of pelvic hematoma is 40%, and varies according to the type of hysterectomy and the diagnostic procedure. those hematoma increase the risk for infection. diagnosis usually is not a clinical one unless symptoms occur, and then the diagnosis is made by ct or ultrasound. number of interventions are mentioned in the literature to try and decrease post operative complications and infections, none have suggested effective enough. this is a prospective study which objective is to characterize the incidence of pelvic hematoma following hysterectomy using ultrasound. the investigators will also try to identify preoperative, intraoperative and postoperative risk factors for infection of this hematomas. this identification might decrease the incidence of postoperative hematoma and infection.

Eligibility criteria:
inclusion criteria:women following hysterectomy in the gynecologic division carmel medical center exclusion criteria: * not relevant
ve303 for treatment of hepatic encephalopathy (he)

Conditions: Cirrhosis; Hepatic Encephalopathy

Summary: this research is studying the use of a new drug to learn about its safety and efficacy as a treatment for hepatic encephalopathy. eligible participants will be enrolled and given oral antibiotics followed by 14 days of the study drug (placebo vs.ve303). there will be visits as well as other procedures to collect blood and stool samples, and have tests of your cognition (thinking) for this research study. the hypothesis is that ve303 will safely and effectively improve cognitive function in patients with a history of overt hepatic encephalopathy.


Eligibility criteria:
inclusion criteria: * diagnosis of cirrhosis based on liver biopsy, imaging, or evidence of clinical decompensation * history of at least one episode of overt he any time in the past * prescribed both lactulose and rifaximin, and compliant with this treatment exclusion criteria: * current episode of overt he * variceal bleeding in the last 4 weeks * gut-absorbable or intravenous antibiotic therapy in the last 28 days * fecal microbiota transplant in the last 6 months * use of probiotics in the last 2 weeks * alcohol or illicit drug intake in the last 4 weeks * primary sclerosing cholangitis as etiology of liver disease * history of inflammatory bowel disease, short gut, gastrointestinal tract fistulas, intestinal ischemia, or any form of ongoing colitis * prior diagnosis of dementia or other primary neurocognitive disorder * known hypersensitivity/allergy/intolerance to vancomycin and any ingredients of ve303: sucrose, histidine, yeast extract, cysteine, metabisulfite, and microcrystalline cellulose * history of roux-en-y gastric bypass * any gastrointestinal surgery in the last year * substantial immune compromise/deficiency (e.g., uncontrolled human immunodeficiency virus, active immune suppressive therapy including high doses of corticosteroids or medications to prevent graft rejection, recent myeloablative therapy, sustained neutropenia) * pregnancy or breast feeding * model for end-stage liver disease (meld) \> 20 * history of spontaneous bacterial peritonitis * hemodialysis in the last 28 days * placement of a portosystemic shunt or transjugular intrahepatic portosystemic shunt in the last 3 months (permissible if placed \>3 months before enrollment) * unstable doses of opiates, benzodiazepines or other sedating medication * chronic methadone or low dose benzodiazepines (for example) is acceptable
prevalence and kinetics of diaphragmatic dysfunction in elderly patients with acute respiratory distress

Conditions: Respiratory Distress Syndrome, Adult

Summary: acute respiratory distress (ard) is one of the most frequent reasons for consultation and hospitalization in emergency medicine. the use of ultrasound methods as a diagnostic and clinical assessment tool in emergency medicine is increasingly important. as such, ultrasound is a simple, non-invasive means of assessing diaphragmatic function in the patient's bed. several methods of ultrasound assessment of diaphragm function have been described. among these different methods, the diaphragmatic excursion seems to have a better intra and interobserver reproducibility as well as a greater feasibility, in particular because of its speed of realization and its learning curve seeming faster in comparison with the measurement. of the thickening fraction. measuring the diaphragmatic excursion could therefore ultimately represent a simple means of assessing respiratory function, both diagnostic and prognostic, in patients with acute respiratory distress in the emergency departments. the etiologies of acute respiratory distress in very elderly patients (i.e.\> 75 years) admitted to the emergency reception service are multiple. to our knowledge, there is no data available in the literature on the prevalence of diaphragmatic dysfunction and its short- and long-term course in this category of patients. the main objective of this study is therefore to assess the prevalence of diaphragmatic dysfunction and its evolutionary kinetics in patients over the age of 75 admitted for acute respiratory distress in the emergency medicine department.


Eligibility criteria:
inclusion criteria: * patient in spontaneous ventilation at the admission on emergency room * presence of acute respiratory distress defined by at least 1 of the following criteria: * respiratory rate \> 25/min and/or clinical signs of acute respiratory distress, * hypoxia defined by sp02 \< 90 %, * hypercapnia defined by pac02 \> 45 mmhg with respiratory acidosis defined by a ph value \<7.35. * absence of opposition of the patient to his participation in the study and the use of his data or the trusted person if the state of the patient does not allow it. exclusion criteria: * presence of a preexisting diaphragmatic dysfunction appearing in the history or the medical file of the patient and explored on the electro-physiological level, * patient with acute respiratory distress on arrival at the sau with clinical criteria justifying immediate use of invasive mechanical ventilation and not allowing ultrasound measurements to be carried out or patient admitted to the sau with mechanical ventilatory support from the outset, * poor command of the french language or state incompatible with the patient's understanding and / or informed adherence to the study protocol, * history of surgery involving the integrity of the diaphragmatic muscle (diaphragm plication or diaphragmatic lumpectomy or placement of diaphragmatic pacemaker), * criteria for shock or severe hemodynamic instability, * intra-cranial hypertension.
body temperature in persons with tetraplegia when exposed to heat

Conditions: Spinal Cord Injury

Summary: the deleterious effects of hyperthermia are well appreciated in able-bodied persons. however, the consequences of impaired regulation of normal body temperature on cognitive performance of persons with tetraplegia is not known. this study will provide the preliminary findings necessary for future work to design and explore physical and medical interventions to improve temperature regulation in those with tetraplegia with the goal of improved clinical care, health, and quality of life. the proposed study consists of 1 visit during which 20 subjects (10 with tetraplegia, 10 controls) will be exposed to 81°f for 40 minutes and then 95° f for up to 2 hours. physiological as well as psychological processes will be monitored in all subjects during the study for safety and to determine differences in responses to exposure to hot ambient temperatures

after a cervical spinal cord injury (sci) the motor, sensory and autonomic deficits cause, among other detriments, a blunted ability to maintain a constant core temperature. impaired thermoregulation leaves persons with tetraplegia more susceptible to hyperthermia than able-bodied persons (ab). there has been a paucity of work addressing the thermoregulatory responses of persons with sci to hot ambient temperatures, and even less study addressing the effect of these temperatures on cognitive performance. the goals of this pilot study are: to improve our understanding of the thermoregulatory mechanisms of individuals with tetraplegia when exposed to heat and to determine the effect of impaired thermoregulatory mechanisms on cognitive performance during exposure to 35°c for up to 2 hours. in order to address our goals we have designed a study methodology which consists of comparing the physiological and psychological responses of the two study groups (tetraplegia versus ab controls) from thermoneutral (27°c) to hot (35°c) environments.

Eligibility criteria:
inclusion criteria: 1. between 18 and 65 years of age; 2. duration of injury ≥ 1 year; 3. level of sci c4-t1; 4. euhydration (subjects will be instructed to avoid caffeine and alcohol, maintain normal salt and water intake, and avoid strenuous exercise for 24 hours prior to study); and 5. age (± 5 years) and gender matched ab control group. exclusion criteria: 1. known heart and/or blood vessel disease; 2. high blood pressure; 3. kidney disease; 4. diabetes mellitus; 5. acute illness or infection; 6. dehydration; 7. pregnant women; 8. untreated thyroid disease, and 9. broken, inflamed, or otherwise fragile skin.

Keywords: spinal cord injury body temperature executive function sweat
physiotherapy for chronic metatarsalgia

Conditions: Metatarsalgia

Summary: the pilot study was conducted in the form of an open prospective single-arm observational study with 28 patients who received physiotherapy at the spiraldynamik® med center in zurich.

the pilot study was conducted in the form of an open prospective single-arm observational study. the data of 28 patients who received physiotherapy at the spiraldynamik® med center in zurich was evaluated. the endpoints of visual analog scale foot and ankle (vas fa), activity index (ai), plantar and inter-metatarsal pres-sure pain, rearfoot angle and dorsal extension capability of the upper ankle joint were individually compared and analyzed before and after therapy.

Eligibility criteria:
inclusion criteria: * main diagnosis: metatarsalgia * secondary diagnosis: hallux rigidus,hallux valgus, knick-senk-spreizfuß, hohlfuß * age 30-75 jahre, gender both * chronic ( ≥ 3 month), * pain ≥ 1 visuell analog scale (vas) * no other complementary therapy exclusion criteria: * local: trauma, fracture, tumore, infectionen * pain after forefoot - operation * neurological diseases * generell: somatoform, pension covet
the nordic-baltic randomized registry study for evaluation of pci in chronic total coronary occlusion

Conditions: Chronic Total Occlusion of Coronary Artery; Heart Failure; Angina Pectoris

Summary: randomized registry for the study of cto pci as adjunction to optimal medical therapy.


Eligibility criteria:
inclusion criteria: * ≥1 cto lesion amenable to pci. * stable and stabilized coronary artery disease * symptoms (angina pectoris or shortness of breath) and/or signs of reversible perfusion defect by spect, pet or mr and/or angiographic/echocardiographic indication of reversible ischemia. * cto lesion in a major coronary vessel supplying a significant myocardial territory (vessel diameter usually ≥3mm). exclusion criteria: * expected survival \<1 year. * renal failure on dialysis. * stable non-cto lesions treated within one month. * declined informed consent. * regarding cmr: allergy to contrast medium, severe obesity, claustrophobia and certain metallic implants

Keywords: chronic total occlusion cto pci percutaneus coronary intervention
safety, efficacy and tolerability of vilazodone in (gad) generalized anxiety disorder

Conditions: Generalized Anxiety Disorder

Summary: the purpose of this study is to evaluate the efficacy, safety, and tolerability of vilazodone relative to placebo in the treatment of generalized anxiety disorder (gad).


Eligibility criteria:
inclusion criteria: * male or female outpatient, 18-70 years of age * currently meet the diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) criteria for generalized anxiety disorder * minimum score of 20 on hamilton rating scale for anxiety exclusion criteria: * women who are pregnant or who will be breastfeeding during the study * patients with a history of: 1. any manic or hypomanic or mixed episode, including bipolar disorder and substance-induced manic, hypomanic or mixed episode 2. any depressive episode with psychotic or catatonic features 3. panic disorder with or without agoraphobia

Keywords: generalized anxiety disorder, gad
rct - assessing the benefits of the use of a tension night splint in patients with plantar fasciitis

Conditions: Plantar Fasciitis

Summary: to assess whether the provision of a tension night splint (tns) device has any additional benefit in patients with chronic plantar fasciitis, compared to routine care comprising physiotherapy \& podiatry alone.


Eligibility criteria:
inclusion criteria: 1. patients age \>18 with symptoms of plantar fasciitis for \>3 months 2. diagnostic imaging confirming plantar fasciitis (either us or mri acceptable) exclusion criteria: 1. current or previous partial or full-thickness tear of the achilles tendon or plantar fascia (either clinically suspected or proven on imaging) 2. current or previous calf muscle injury 3. previous use of tension night splint 4. diabetic neuropathy, or other sensory / sensorimotor disturbance 5. lower limb vascular compromise 6. fragile skin, or skin wounds on lower leg 7. subjects with impaired mobility which prevents safe and effective application of the tension night splint 8. any other condition which it is thought may be aggravated by the use of a tension night splint 9. subjects unable to give valid consent for the study 10. subjects who state that they are unable or unwilling to undergo the home-based structured rehabilitation programme as a part of the study process 11. subjects who are unable to attend the follow-up appointment required at the end of the study